Company names starting with "K"

Patents whose numbers are in italics have been extended under 35 USC 156. Unless otherwise noted, all expiration dates include applicable Sec. 156 and pediatric (PED) extensions.


Kamada Ltd.
Cytogam (Injection) (Intravenous) Cytomegalovirus Immune Globulin Intravenous (Human)
Drug Classes: Immunological Agents:Immunoglobulins
NDA Applicant: Kamada Ltd.      BLA No.: 103189  Prod. No.: 001 Rx (2.5G/50ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityDec 4, 2005Orphan Designation: Prevention or attenuation of primary cytomegalovirus disease in immunosuppressed recipients of organ transplants.
Approved Labeled Indication: #1) Attenuation of primary CMV disease associated with kidney transplant recipients who are seronegative for CMV and who receive a kidney from a CMV seropositve donor; #2) Prophylaxis of CMV disease associated transplantation of kidney (all other), lung, liver, pancreas and heart.
Exclusivity Type: Orphan Drug ExclusivityOct 4, 2005Orphan Designation: This Orphan Designation could not be obtained via our automated process due to a trademark mismatch between the Purple Book and the FDA's "Orphan Drug Designations and Approvals" search engine. Please use the FDA's search engine to manually look up the orphan designation.

Kamada Ltd.
Hepagam B (Injection) (Intramuscular) Hepatitis B Immune Globulin (Human)
Drug Classes: Immunological Agents:Immunoglobulins == Immunological Agents:Vaccines
NDA Applicant: Kamada Ltd.      BLA No.: 125035  Prod. No.: 001 Rx (>1560IU/5ML); 002 Rx (>312IU/ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityApr 6, 2014Orphan Designation: Prevention of hepatitis B recurrence following orthotopic liver transplant
Approved Labeled Indication: Prevention of hepatitis B recurrence following liver transplantation in HBsAG-positive liver transplant patients

Kamada Ltd.
Varizig (For Injection) (Intramuscular) Varicella Zoster Immune Globulin (Human)
Drug Classes: Immunological Agents:Immunoglobulins == Immunological Agents:Vaccines
NDA Applicant: Kamada Ltd.      BLA No.: 125430  Prod. No.: 002 Rx (125IU) BLA No.: 125430  Prod. No.: 001 Disc (125IU)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityDec 20, 2019Orphan Designation: Passive immunization for the treatment of exposed, susceptible individuals who are at risk of complications from varicella
Approved Labeled Indication: Post exposure prophylaxis of varicella in high risk individuals to reduce the severity of varicella

Kamada Ltd.
Winrho Sd, Winrho Sdf Liquid, Winrho Sdf Lyophilized (For Injection) (Intravenous; Intramuscular) Rho(D) Immune Globulin Intravenous (Human)
Drug Classes: Immunological Agents:Immunoglobulins
NDA Applicant: Kamada Ltd.      BLA No.: 103649  Prod. No.: 004 Rx (600IU); 005 Rx (1500IU); 007 Rx (5000IU); 013 Rx (600IU); 014 Rx (1500IU); 016 Rx (5000IU) BLA No.: 103649  Prod. No.: 001 Disc (600IU); 002 Disc (1500IU); 003 Disc (5,000IU); 006 Disc (2500IU); 008 Disc (15000IU); 009 Disc (3000IU); 010 Disc (600IU); 011 Disc (1500IU); 012 Disc (5,000IU); 015 Disc (2500IU); 017 Disc (15000IU); 018 Disc (3000IU)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMar 24, 2002Orphan Designation: This Orphan Designation could not be obtained via our automated process due to a trademark mismatch between the Purple Book and the FDA's "Orphan Drug Designations and Approvals" search engine. Please use the FDA's search engine to manually look up the orphan designation.

Kiniksa Pharmaceuticals (UK), Ltd.
Arcalyst (For Injection) (Subcutaneous) rilonacept
Drug Classes: Immunological Agents:Immunological Agents, Other
NDA Applicant: Kiniksa Pharmaceuticals (UK), Ltd.      BLA No.: 125249  Prod. No.: 001 Rx (220MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityFeb 27, 2015Orphan Designation: Treatment of CIAS1-Associated Periodic Syndromes
Approved Labeled Indication: Treatment of Cryopyrin-Assisted Periodic Syndromes (CAPS)
Exclusivity Type: Orphan Drug ExclusivityMar 18, 2028Orphan Designation: Treatment of pericarditis
Approved Labeled Indication: Treatment of recurrent pericarditis (RP) and reduction in risk of recurrence in adults and pediatric patients 12 years and older
Exclusivity Protected Indication: Treatment of recurrent pericarditis (RP) and reduction in risk of recurrence in adults and pediatric patients 12 years and older

Kite Pharma Inc.
Tecartus (For Injection) (Intravenous) Brexucabtagene Autoleucel
NDA Applicant: Kite Pharma Inc.      BLA No.: 125703  Prod. No.: 001 Rx (2×10^6 CAR-positive viable T cells per kg body weight)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJul 24, 2027Orphan Designation: Treatment of mantle cell lymphoma.
Approved Labeled Indication: TECARTUS_ is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL)
Exclusivity Protected Indication: TECARTUS_ is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL)
Exclusivity Type: Orphan Drug ExclusivityOct 1, 2028Orphan Designation: Treatment of acute lymphoblastic leukemia (ALL)
Approved Labeled Indication: Treatment of adult patients with relapsed or refractory B-cell precursor acute lymphomblastic leukemia (ALL)
Exclusivity Protected Indication: Treatment of adult patients with relapsed or refractory B-cell precursor acute lymphomblastic leukemia (ALL)

Kite Pharma Inc.
Yescarta (Injection) (Intravenous) axicabtagene ciloleucel
Drug Classes: CD19-directed genetically modified autologous T-cells
NDA Applicant: Kite Pharma Inc.      BLA No.: 125643  Prod. No.: 001 Rx (2 × 10^6 CAR-POSITIVE VIABLE T CELLS PER KG OF BODY WEIGHT)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityOct 18, 2024Orphan Designation: Treatment of primary mediastinal B-cell lymphoma.
Approved Labeled Indication: Treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma
Exclusivity Protected Indication: Treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy, treatment of adult patients with relapsed or refractory DLBCL arising from follicular lymphoma after two or more lines of systemic therapy, and treatment of adult patients with relapsed or refractory primary mediastinal B-cell lymphoma after two or more lines of systemic therapy (not including treatment of patients with primary central nervous system lymphoma)
Exclusivity Type: Orphan Drug ExclusivityOct 18, 2024Orphan Designation: Treatment of diffuse large B-cell lymphoma
Approved Labeled Indication: Treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma
Exclusivity Protected Indication: Treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy, treatment of adult patients with relapsed or refractory DLBCL arising from follicular lymphoma after two or more lines of systemic therapy, and treatment of adult patients with relapsed or refractory primary mediastinal B-cell lymphoma after two or more lines of systemic therapy (not including treatment of patients with primary central nervous system lymphoma)
Exclusivity Type: Orphan Drug ExclusivityOct 18, 2024Orphan Designation: Treatment of follicular lymphoma.
Approved Labeled Indication: Treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma
Exclusivity Protected Indication: Treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy, treatment of adult patients with relapsed or refractory DLBCL arising from follicular lymphoma after two or more lines of systemic therapy, and treatment of adult patients with relapsed or refractory primary mediastinal B-cell lymphoma after two or more lines of systemic therapy (not including treatment of patients with primary central nervous system lymphoma)
Exclusivity Type: Orphan Drug ExclusivityMar 5, 2028Orphan Designation: Treatment of follicular lymphoma.
Approved Labeled Indication: Treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy
Exclusivity Protected Indication: Treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy, excluding patients with diffuse large B-cell lymphoma arising from follicular lymphoma.

Kyowa Kirin, Inc.
Crysvita (Injection) (Subcutaneous) burosumab-twza
NDA Applicant: Kyowa Kirin, Inc.      BLA No.: 761068  Prod. No.: 001 Rx (10MG/ML); 002 Rx (20MG/ML); 003 Rx (30MG/ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityApr 17, 2025Orphan Designation: Treatment of X-linked hypophosphatemia (formerly known as vitamin D-resistant rickets)
Approved Labeled Indication: CRYSVITA is indicated for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 1 year of age and older
Exclusivity Protected Indication: CRYSVITA is indicated for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 1 year of age and older
Exclusivity Type: Orphan Drug ExclusivitySep 27, 2026Orphan Designation: Treatment of X-linked hypophosphatemia (formerly known as vitamin D-resistant rickets)
Approved Labeled Indication: CRYSVITA is indicated for the treatment of X-linked hypophosphatemia (XLH) in adult and pediatric patients 6 months of age and older.
Exclusivity Protected Indication: For the treatment of X-linked hypophosphatemia (XLH) in pediatric patients 6 months of age to less than 1 year of age
Exclusivity Type: Orphan Drug ExclusivityJun 18, 2027Orphan Designation: Treatment of tumor-induced osteomalacia (TIO) syndrome
Approved Labeled Indication: Crysvita (burosumab-twza) is indicated for the treatment of FGF23-related hypophosphatemia in tumor-induced osteomalacia (TIO) associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized.
Exclusivity Protected Indication: For the treatment of FGF23-related hypophosphatemia in tumor-induced osteomalacia (TIO) associated with phosphaturic mesenchymal tumors that cannot be curatively resected or localized in adult and pediatric patients 2 years of age and older

Kyowa Kirin, Inc.
Poteligeo (Injection) (Intravenous) mogamulizumab-kpkc
NDA Applicant: Kyowa Kirin, Inc.      BLA No.: 761051  Prod. No.: 001 Rx (20MG/5ML (4MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityAug 8, 2025Orphan Designation: Treatment of patients with cutaneous T-cell lymphoma.
Approved Labeled Indication: POTELIGEO is indicated for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or S_zary syndrome (SS) after at least one prior systemic therapy.
Exclusivity Protected Indication: POTELIGEO is indicated for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or S_zary syndrome (SS) after at least one prior systemic therapy.



Last edited: 15 November 2022
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